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Womble Bond Dickinson IP Partner Karthika Perumal, Ph.D. will speak at the FDA and the Changing Paradigm for HCT/P Regulation event, which takes place April 12-13 in Cambridge, MD.
Dr. Perumal will speak on “Bridging the Gap Between 361 HCT/Ps and HCT/Ps Regulated as Drugs, Devices and/or Biological Products.” She will provide insight to industry stakeholders on steps needed to begin clinical trials to support marketing applications for human cells, tissues, and cellular and tissue-based products. Amnio Technology Associate Director of Regulatory Affairs Tiana Golding will moderate the discussion.
Other discussion topics at the two-day event will include:
• Core cGTP Requirements;
• Transmission of Mycobacterium Tuberculosis through Bone Grafts;
• FDA/DHT Update; and
• HCT/P Regulatory Framework.
The conference will have strong representation from FDA and many industry experts crossing the broad spectrum of tissues, cells, and cellular and tissue-based products
